On February 20, 2018, the United States Food and Drug Administration (US FDA) finalized a rule that requires medical device clinical investigations conducted outside the US to flexibly conform with good clinical practice (GCP) standards47.

Good clinical practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects. Compliance with this standard provides public assurance that the rights, safety, and wellbeing of trial subjects are protected, consistent with the principles that have their origin in the Declaration of Helsinki, and that the clinical trial data are credible48.

The new rule requires that sponsors and applicants provide statements and information about how their clinical investigations conform with GCP.

The new rules apply to clinical data submitted to support investigational device exemptions (IDE), premarket notifications (510(k)), requests for De Novo classification, premarket approvals (PMA), product development protocols (PDP), and humanitarian device exemptions (HDE). The final rule also amends the IDE, 510(k) and HDE regulations for FDA acceptance of data from clinical investigations conducted within the US to require a statement regarding compliance with FDA regulations for human subject protection, institutional review boards, and IDEs.

In addition to the rule, FDA has also published a guidance on "Acceptance of Clinical Data to Support Medical Device Applications and Submissions Frequently Asked Questions49." The question and answer guidance provides clarifications and recommendations to help ensure that studies conducted in the US or foreign countries comply with the new rule and revised regulations.

Summary of the Major Provisions of the Final Rule

This rule requires that sponsors and applicants of submissions and applications, that include clinical investigations conducted outside the United States and submitted to support an IDE or device marketing application or submission, provide statements and information regarding how the investigations conform with GCP. FDA defines GCP as a standard for the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical investigations in a way that provides assurance that the data and results are credible and accurate and that the rights, safety, and well-being of subjects are protected. GCP includes review and approval by an IEC (Independent Ethics Committee) before initiating an investigation, continuing IEC review of ongoing investigations and obtaining and documenting the freely given informed consent of subjects.

FDA is also including requirements for the acceptance of data from clinical investigations conducted in the United States submitted to support an IDE application, an HDE application, or a premarket notification submission. The changes require a statement regarding compliance with FDA regulations for human subject protection, institutional review boards, and IDEs when the investigations are conducted in the United States. With the above described changes, the rule is intended to update the standards for FDA acceptance of data from clinical investigations and to help ensure the quality and integrity of data obtained from these investigations and the protection of human subjects.

Effective Date

The effective date will be 1 year after the publication of this final rule in the Federal Register. This final rule will apply to all clinical investigations that enroll the first subject on or after the effective date of this rule.

Conclusion:

Conformance of investigations with GCP in support of device applications and submissions ensures that the FDA's decisions are based on scientifically valid and ethically derived data. Conformance with GCP is one way to help ensure credible, accurate, and ethically procured clinical data.

Footnotes

47. https://s3.amazonaws.com/public-inspection.federalregister.gov/2018-03244.pdf

48. https://www.fda.gov/downloads/drugs/guidances/ucm073122.pdf

49. https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM597273.pdf

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